The gamma-hydroxybutyric acid or GHB is an endogenous constituent of the mammalian brain, where it exerts a role as neurotransmitter and neuromodulator.
GHB is currently used in the treatment of alcohol addiction, in particular to reduce or prevent symptoms of alcohol withdrawal and the incidence of relapse.
Typically, for pharmacological use, GHB is administered in the form of its sodium salt, known as sodium oxybate.
The pharmacokinetic profile of Sodium oxybate is characterized by some unsatisfactory aspects, including low bioavailability (about 30%) and fast elimination. In fact, although sodium oxybate is quickly absorbed after oral administration, reaching the peak plasma concentration within 30-45 minutes, it is also rapidly eliminated, with a very short half-life (about 30 minutes). This latter pharmacokinetic characteristic requires a frequency of administration corresponding to 3 times a day for obtaining a satisfactory therapeutic outcome.
The short half life of this drug represents a serious drawback since it considerably reduces patient compliance and consequently therapeutic outcomes.
Thus, there is a general need for additional drugs targeted at AUDs treatment, and respect to sodium oxybate, for a drug with a more advantageous pharmacokinetic profile.
One of the general objects of the present invention is to provide a new safe and effective drug for AUDs treatment.
A specific object of the present invention is to provide a compound for the treatment of alcoholism or of alcohol misuse having an improved activity with respect to the compound 4-methoxy-N-[[4-(trifluoromethyl)phenyl]methyl]-butanamide disclosed in WO 98/06690 A1.